Pharma, CRO Fates a Mixed Bag as Pandemic Continues
Pharma companies and CROs are experiencing ups and downs in the second quarter of 2020, with some fighting to keep their trials afloat amidst pandemic uncertainties while others are slowly getting back on track. Here’s a sampling of what happened last week:
- Amid the uncertainty surrounding the COVID-19 pandemic, PRA Health Sciences says it has been working to mitigate the effect of the pandemic on its ongoing studies by using its mobile health platform and remote monitoring technology. Gathering data remotely and supporting virtual trials will help the CRO limit the exposure of staff and conserve valuable resources.
- PPD says it also has been feeling the pandemic pain as some of its customers delay new studies or pause ongoing studies or activities such as recruitment, enrollment, site visits and monitoring. PPD says it is working closely with customers to minimize trial disruptions and ensure continued access to drug supplies for patients in ongoing studies.
In March, the big CRO launched a new program to transfer participants in an affected trial to other research sites. PPD also reports it is working on 39 studies related to COVID-19 treatments and vaccines.
- In a recent report, Ironwood Pharmaceuticals announced it has paused enrollment in a phase 3 trial of its refractory gastroesophageal reflex drug, IW-3718. Most trial sites have stopped in-person screening activities but continue to monitor patients already enrolled and being treated, the company said. As a result, Ironwood will not have top-line data ready to report by the second half of 2020 as planned.
On the other hand, the company’s collaboration with Allergan on a phase 2 trial of MD-7246, a drug to relieve abdominal pain resulting from irritable bowel syndrome, is moving forward and has completed patient dosing, which will allow it to share top-line data in the second quarter of 2020, earlier than the planned target of mid-2020.
- As many clinical trials continue to slow down and some stop altogether, one UK biotech is looking to hit the restart button on enrollment of a phase 3 study. NuCana has announced that it will recommence recruitment of new patients for a study of nucleotide analog Acelarin plus cisplatin for the treatment of biliary tract cancer. The phase 3 trial is designed to enroll up to 828 patients across 120 sites. The first sites to reopen are located in Australia, Canada, South Korea, Taiwan, Ukraine and the UK.